Study of Sildenafil Citrate During and After Radiotherapy/Hormone Therapy for Erectile Function Versus Radiotherapy/Hormone Therapy for Prostate Cancer - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborators:	Mount Sinai School of Medicine Beth Israel Medical Center St. Luke's-Roosevelt Hospital Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00142506

Purpose

Radiation sometimes affects the ability for a person to have a normal erection. Complete loss of erections after radiation treatment can happen in 40-50% of treated patients. There are medications, like sildenafil (also known as Viagra), that can help the ability to get back erections in almost 70% of such patients.

The purpose of this study is to see if taking Viagra every day starting right before, during and for about 6 months after treatment, could reduce the risk of long-term erectile dysfunction.

Condition	Intervention	Phase
Prostate Cancer Erectile Dysfunction	Drug: sildenafil citrate and questionaires Drug: placebo tablets and questionaires	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	This Protocol is a Randomized Prospective Study Comparing Prophylactic and on Demand Sildenafil Citrate Usage Administered During and After Radiotherapy With or Without Hormone Therapy Versus Radiotherapy With or Without Hormone Therapy Alone for the Preservation of Erectile Function After Therapy for Potent Patients With Clinically Localized Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Erectile Dysfunction Prostate Cancer

Drug Information available for: Citric acid Sildenafil Sildenafil citrate Sodium Citrate

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

Determine if prophylactic sildenafil citrate used before, during & after course of radiotherapy (external beam radiotherapy &/or brachytherapy w or w/o hormone therapy) can prevent loss of spontaneous erectile function 2 yrs from start of radiation tx. [ Time Frame: 2 years from start of RT ] [ Designated as safety issue: No ]
Diminish the time to restoration of erectile function for the study population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine if the prophylactic use of sildenafil citrate during radiotherapy may improve the long-term response to the drug following treatment [ Time Frame: 2 years from start of RT ] [ Designated as safety issue: No ]
To determine if sildenafil citrate used during a course of external beam radiotherapy or brachytherapy among patients will reduce acute and late urinary effects of radiotherapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To determine the impact of dosimetry and radiation exposure to both the neurovascular bundle and bulb of the penis on erectile function preservation in the study population undergoing brachytherapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess the impact on quality of life following prophylactic and on demand Sildenafil utilization in the study population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To determine the relationship between testosterone levels, erectile function and efficacy of prophylactic and on demand Sildenafil utilization in the study population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	290
Study Start Date:	February 2005
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 radiotherapy with hormones, questionaire assessments	Drug: sildenafil citrate and questionaires Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months. Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24.
Placebo Comparator: 2 radiotherapy without hormones, questionaire assessments	Drug: placebo tablets and questionaires Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy. In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months. Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24.

Arms

Assigned Interventions

Active Comparator: 1

radiotherapy with hormones, questionaire assessments

Drug: sildenafil citrate and questionaires

Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months.

Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24.

Placebo Comparator: 2

radiotherapy without hormones, questionaire assessments

Drug: placebo tablets and questionaires

Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.

In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months.

Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24.

Detailed Description:

This protocol is a randomized prospective study comparing prophylactic and on demand Sildenafil Citrate usage administered during and after radiotherapy in combination with or without hormone therapy versus radiotherapy alone for the preservation of erectile function in potent patients with clinically localized prostate cancer. The primary objectives of this protocol are to determine if prophylactic and on demand usage of Sildenafil Citrate can preserve spontaneous erectile function as well as diminish the time to restoration of erectile function in potent men receiving radiotherapy with or without hormone therapy for localized prostate cancer. Secondary objectives of this study are: to determine whether prophylactic and on demand use of Sildenafil Citrate during therapy may improve the long-term response to the drug following treatment; to determine whether prophylactic and on demand use of Sildenafil Citrate during therapy will reduce acute and late urinary effects of radiotherapy; to determine the impact of dosimetry and radiation exposure to both the neurovascular bundle and bulb of the penis on erectile function preservation in the study population undergoing brachytherapy and hormone therapy; to asses the impact on quality of life following prophylactic and on demand Sildenafil Citrate usage in the study population; to determine the relationship between testosterone levels, erectile function and efficacy of prophylactic and on demand Sildenafil Citrate usage in the study population.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

To receive external beam radiation therapy and/or brachytherapy for biopsy-proven prostate cancer.
Baseline International Index of Erectile Function (IIEF) erectile function domain score >= 17.
Patients receiving radiotherapy with hormone therapy undergoing a maximum of 9 months of hormone therapy will be acceptable.

Exclusion Criteria:

Baseline IIEF-EF (1-30) domain score of <17 pre-therapy
Current routine use of erectogenic agents (use of agents > 4 times per month would constitute "routine use")
Neoadjuvant androgen deprivation therapy started more than 1 month prior to entry into study (intake of Bicalutamide alone does not constitute exclusion from study entry)
Have a clinically significant penile deformity in the opinion of the investigator (ie: Peyronie's Disease)
Non-organ confined disease
Prior prostate surgery or cryotherapy
Prior prostate radiotherapy started more than 2 weeks prior to entry into study
Currently taking 0.8mg Flomax daily
Penile implant history
Present at baseline with chronic angina requiring nitrates, angina occurring during sexual intercourse or unstable angina within the last 6 months.
History of myocardial infarction, coronary artery bypass graft surgery or percutaneous coronary intervention within 90 days of baseline visit.
History of significant cardiac conduction defect within 90 days of baseline visit.
Exhibit systolic blood pressure > 170 or < 90 mm Hg or diastolic blood pressure > 100 or < 50 mm Hg at baseline visit or have a history of malignant hypertension
Have any condition that would interfere with the subject's ability to provide informed consent or comply with study instructions, would place subject at increased risk, or might confound the interpretation of the study results
Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens (except finasteride taken as Propecia or Proscar)
Have a history of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142506

Locations

United States, New Jersey
Memorial Sloan-Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
United States, New York
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States, 11725
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States, 11570
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States, 10591

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Mount Sinai School of Medicine

Beth Israel Medical Center

St. Luke's-Roosevelt Hospital Center

Investigators

Principal Investigator:

Michael J Zelefsky, M.D.

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Michael Zelefsky, MD, Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00142506 History of Changes
Other Study ID Numbers:	05-007
Study First Received:	August 31, 2005
Last Updated:	July 20, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Prostate Cancer
Cancer of the Prostate
Prostate Neoplasms
Prostatic Cancer
Viagra

Additional relevant MeSH terms:

Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Citric Acid
Hormones

Sildenafil
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012